UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002793 |
|---|---|
| Receipt number | R000003279 |
| Scientific Title | Translational research regarding the effect of TS-1 on CECs from metastatic or relapsed breast cancer patients. |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2013/11/25 23:29:49 |
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Basic information
Public title
Translational research regarding the effect of TS-1 on CECs from metastatic or relapsed breast cancer patients.
Acronym
Translational research regarding the effect of TS-1 on CECs.
Scientific Title
Translational research regarding the effect of TS-1 on CECs from metastatic or relapsed breast cancer patients.
Scientific Title:Acronym
Translational research regarding the effect of TS-1 on CECs.
Region
| Japan |
Condition
Condition
metastatic or relapsed breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effect of TS-1 on circulating endothelial cells.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the changes of CECs or CEPs from the patients treated with TS-1.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Internal use of TS-1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)
Key exclusion criteria
1)
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Toi |
Organization
Kyoto University Hospital
Division name
Breast Surgery Department
Zip code
Address
54 kawara-cho shogoin sakyo-ku kyoto city, Japan
TEL
075-751-3660
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakako Tsuji |
Organization
Kyoto University Hospital
Division name
Breast Surgery Department
Zip code
Address
54 kawara-cho shogoin sakyo-ku kyoto city, Japan
TEL
075-751-3660
Homepage URL
w-sato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital, Breast Surgery Department
Institute
Department
Personal name
Funding Source
Organization
Taiho Phamaceutical Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院(京都府)、天理よろづ相談所病院（奈良県）、田附興風会医学研究所北野病院（大阪府）、三菱京都病院（京都府）、公立甲賀病院（滋賀県）、彦根市立病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 24 | Day |
Last modified on
| 2013 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
